DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of the species of at least three biomarkers of SLC7A11, SERPINE1, and PSAT1 in the reply filed on 29 April 2026 is acknowledged. The traversal is on the ground(s) that the recited prior art (Kalyanaraman) does not disclose any combination of biomarkers of the anti-cancer efficacy of a compound such as MitoQ and there is no significant burden of search. The argument that Kalyanaraman does not disclose any combination of biomarkers of the anti-cancer efficacy of a compound such as MitoQ is not found persuasive because the shared technical feature of the species is the treatment of an individual with a mitochondria-targeted antioxidant as no biomarker is shared among all species encompassed by the claim (e.g., a first species wherein the at least three biomarkers are SLC7A11, SERPINE1, and PSAT1 and a second species wherein the at least three biomarkers are VIM, SNAI1, and ZEB1). Regarding the argument that there is no significant burden of search, as the instant application is a 371, the standard for restriction is unity of invention, which does not require a significant search or examination burden.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statements (IDS) filed 21 November 2023 and 29 January 2024 are considered, initialed, and attached hereto.
Claim Status
Claims 18-37 are pending and under examination.
Claims 1-17 are canceled.
Specification
The use of terms such as MitoQ, SpectraMax, and CellTiter-Glo, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 18, 20, 28, 33, and 37 objected to because of the following informalities:
Claim 18 lines 11 and 16 recite “their respective reference levels”. However, no reference level is given in the claim. It appears clear to the examiner that the respective reference level is intended to refer to the expression level of the respective biomarker in the sample obtained before treatment. Correction by either (a) defining in the claim the expression levels in the sample obtained before treatment as the reference levels or (b) replacing “their respective reference levels” in line 9 with “their respective expression levels” and “the expression levels of at least three biomarkers as compared to their respective references levels” in lines 15-16 with “the expression levels of the at least three biomarkers in the samples obtained after treatment as compared to their respective expression levels in the samples obtained before treatment” would cure this objection.
Claim 20 lines 2-3 recites “expression levels of at least three biomarkers as compared to their respective reference levels”, which is objected to for the same reason as claim 18 above and should be corrected in the same manner as claim 18 is corrected.
Claim 18 line 15 recites “of at least three biomarkers”, which should be corrected to “of the at least three biomarkers”.
Claim 18 lines 17-18 recites “a treatment by a mitochondria-targeted antioxidant”, which should be corrected to “a treatment by [the or said] mitochondria-targeted antioxidant”.
Claim 18 in lines 4, 9, 12, and 17 recites “a. assessing”, “b. comparing”, “c. identifying”, and “d. treating”, respectively. MPEP §608.01(m) states: “Each claim begins with a capital letter and ends with a period”. Applicant is suggested to replace the period used to distinguish the steps with another marker, as in examples such as (a) or a).
Claim 28 line 1 recites “18,,”, the extraneous comma should be deleted.
Claim 33 line 1 and claim 37 line 1 recite “the antioxidant”, which should be corrected to “the at least one mitochondria-targeted antioxidant”.
Appropriate correction is required.
Claim Interpretation
Claim 18 recites in lines 13-16 step c), “identifying an individual with cancer as being susceptible to respond to a treatment by said at least one mitochondria-targeted antioxidant, when a significant variation of the expression levels of at least three biomarkers as compared to their respective reference levels is observed at step b)” (emphasis added). The phrase “when a significant variation […] is observed at step b)”, makes the step “identifying an individual with cancer as being susceptible to respond to a treatment by said at least one mitochondria-targeted antioxidant” clearly contingent on a significant variation being observed at step b). Furthermore, step d) in lines 17-20 of claim 18 only applies to an individual and treatment identified in step c) and therefore is also contingent on a significant variation being observed at step b). However, the method of claim 18 does not require that there is a significant variation observed at step b), as it does not exclude, for example, individuals for whom none of the listed biomarkers differ in expression before and after treatment. MPEP §2111.04 states: “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met”. Therefore, the broadest reasonable interpretation of the method of claim 18 only requires steps a) and b).
The instant specification provides a limiting definition for the “mitochondria-targeted antioxidant” recited in the claims. Paragraph [0060] recites “As used herein the term “mitochondria-targeted antioxidant” refers to an antioxidant that can accumulate inside mitochondria and scavenge and/or inactivate and/or prevents the production of one or more reactive oxygen species (ROS)”.
The instant specification provides a limiting definition for the expression “before treatment” recited in the claims. Paragraph [0092] recites “As used herein, the expression “before treatment” means that the sample may be collected from about 6 h to about 10 days prior to the initiation of the treatment”.
The instant specification provides a limiting definition for the expression “after treatment” recited in the claims. Paragraph [0095] recites “As used herein, the expression “after treatment” means that the sample may be collected from about 6 h to about 10 days after the end of the treatment”.
MPEP §2111.02 II. states: “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. Since the body of claims 30 and 34 recite a complete invention comprising the administration of a therapeutically efficient amount of at least one mitochondria-targeted antioxidant, claim 30’s recitation in the preamble of “for preventing and/or treating cancer in an individual identified by the method of claim 18” and claim 34’s recitation in the preamble of “for preventing and/or treating cancer before, concomitantly or after a surgery intended to remove all or part of the tumor in an individual identified by the method of claim 18” are interpreted as intended uses of the respective methods that do not limit the scope of the respective claims.
Claim Rejections - 35 USC § 112(b) - Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18-37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “significant” in claim 18, line 15 is a relative term which renders the claim indefinite. The term “significant” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the claim are unclear to one of ordinary skill in the art, since it would be unclear to one of ordinary skill in the art what amount of variation is necessary to fall within the scope of the phrase “significant variation”. For example, a certain level of statistical significance (such as p<0.05 or p<0.001) using a specific statistical test or a specific fold-change would be definite alternatives to “significant variation”. Claims 19 and 21-37 are also rejected based on their dependency on claim 18 (claim 20 is not rejected because it further limits “significant variation” to definite bounds).
Claim 18 recites the limitation "the individual" in line 17. There is insufficient antecedent basis for this limitation in the claim. Claim 18 introduces “an individual” in line 1 and “an individual” in line 13, so it would be unclear to one of ordinary skill in the art to which individual “the individual” of line 17 draws antecedent basis. Claims 19-37 are also rejected based on their dependency on claim 18.
Claims 19 and 27 recite the limitation "the cancer" in line 1 of each claim. There is insufficient antecedent basis for this limitation in the claim. Both claims 19 and 27 depend upon claim 18, which introduces a “an individual with cancer” in line 1 and “an individual with cancer” in line 12, so it would be unclear to one of ordinary skill in the art the cancer of which individual that “the cancer” of claims 19 and 27 draw antecedent basis from.
Claim 25 recites the limitation “wherein the biomarkers are SLC7A11, SERPINE1, PSAT1, PHGDH-1, TXNRD1, VIM, SNAI1, ZEB1, NANOG, SOX2, PCK2, G6PD, ASNS, NUPR1 and SLC6A9” in lines 1-3. It would be unclear to one of ordinary skill in the art whether this limitation limits the at least three biomarkers selected (i.e. the selected biomarkers are SLC7A11, SERPINE1, PSAT1, PHGDH-1, TXNRD1, VIM, SNAI1, ZEB1, NANOG, SOX2, PCK2, G6PD, ASNS, NUPR1 and SLC6A9) or whether this limitation limits the list of biomarkers that the at least three biomarkers are selected from. In the latter case, claim 25 would also be rejected under 35 U.S.C. 112(d) for failing to further limit claim 18 upon which it depends. Therefore, for the purpose of examination, the former interpretation is used.
Claims 28-29, 32, and 36 contain the trademark/trade name MitoQ. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a specific mitochondria-targeted antioxidant sold and, accordingly, the identification/description is indefinite. For the purpose of examination, recitations of MitoQ in the claims are interpreted to refer to mitoquinone mesylate.
Claim 28 recites “wherein the at least one mitochondria-targeted antioxidant is selected from the group consisting of […] C12TPP”. However, C12TPP is not a mitochondrial-targeted antioxidant, since it is the mitochondrial-targeting fragment of SKQ1 without the antioxidant quinone moiety, as taught in the prior art of Chelombitko et al. (“Comparison of the Effects of Mitochondria-Targeted Antioxidant 10-(6’-Plastoquinonyl)Decyltriphenylphosphonium Bromide (SkQ1) and a Fragment of its Molecule Dodecyltriphenylphosphonium on Carrageenan-Induced Acute Inflammation in Mouse Model of Subcuteneous Air Pouch” Bull Exp Biol Med 162(6), pages 730-733 (2017); see page 730 right column paragraph 2). Therefore, the inclusion of C12TPP in the group from which the at least one mitochondria-targeted antioxidant is selected introduces a contradiction. Due to this contradiction, it would be unclear to one of ordinary skill in the art whether using C12TPP as the mitochondrial-targeted antioxidant falls within the metes and bounds of claim 28.
Claim 31 recites the limitation "the cancer" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 31 depends upon claim 30, which itself depends upon claim 18, which introduces a “an individual with cancer” in line 1 and “an individual with cancer” in line 12, so it would be unclear to one of ordinary skill in the art the cancer of which individual that “the cancer” of claim 31 draws antecedent basis from.
Claim 32 recites the limitation "the at least one mitochondria-targeted antioxidant" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 32 depends upon claim 30, which introduces “at least one mitochondria-targeted antioxidant” in line 3, and which itself depends upon claim 18, which introduces “at least one mitochondria-targeted antioxidant” in line 2, so it would be unclear to one of ordinary skill in the art which at least one mitochondria-targeted antioxidant that “the at least one mitochondria-targeted antioxidant" of claim 32 draws antecedent basis from.
Claim 33 recites the limitation "the antioxidant" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 33 depends upon claim 30, which introduces “at least one mitochondria-targeted antioxidant” in line 3, and which itself depends upon claim 18, which introduces “at least one mitochondria-targeted antioxidant” in line 2, so it would be unclear to one of ordinary skill in the art which antioxidant that “the antioxidant" of claim 33 draws antecedent basis from.
Claim 35 recites the limitation "the cancer" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 35 depends upon claim 34, which itself depends upon claim 18, which introduces a “an individual with cancer” in line 1 and “an individual with cancer” in line 12, so it would be unclear to one of ordinary skill in the art the cancer of which individual that “the cancer” of claim 31 draws antecedent basis from.
Claim 36 recites the limitation "the at least one mitochondria-targeted antioxidant" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 36 depends upon claim 34, which introduces “at least one mitochondria-targeted antioxidant” in line 4, and which itself depends upon claim 18, which introduces “at least one mitochondria-targeted antioxidant” in line 2, so it would be unclear to one of ordinary skill in the art which at least one mitochondria-targeted antioxidant that “the at least one mitochondria-targeted antioxidant" of claim 36 draws antecedent basis from.
Claim 37 recites the limitation "the antioxidant" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 37 depends upon claim 34, which introduces “at least one mitochondria-targeted antioxidant” in line 4, and which itself depends upon claim 18, which introduces “at least one mitochondria-targeted antioxidant” in line 2, so it would be unclear to one of ordinary skill in the art which antioxidant that “the antioxidant" of claim 37 draws antecedent basis from.
Claim Rejections - 35 USC § 112(a) - Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 18-37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification and prior art, while being enabling for identifying a human individual with breast cancer as susceptible to treatment by a mitochondria-targeted antioxidant and treating said individual, enabling for treating neuroblastoma, prostate, or breast cancer in a human individual, and enabling for preventing or treating human breast cancer recurrence in a mouse individual, does not reasonably provide enablement for identifying and treating any individual with any cancer, preventing and/or treating any cancer in any individual, or preventing and/or treating any cancer recurrence in any individual. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Scope of the Claims/Nature of the Invention
Claims 18-29 are drawn to a method for identifying an individual with cancer and being susceptible to respond to a treatment by at least one mitochondria-targeted antioxidant and treating said individual. Claims 30-33 are drawn to a method for preventing and/or treating cancer in an individual. Claims 34-37 are drawn to a method for preventing and/or treating cancer recurrence in an individual. In view of the recitations of “individual” (claim 18 line 1, claim 30 line 1, claim 34 line 2) and “cancer” (claim 18 line 1, claim 30 line 1, claim 34 line 1) and the lack of any limiting definition in the instant specification of individual or cancer, claims 18 and 20-29 encompass identifying and treating ANY individual with ANY type of cancer, claims 30 and 32-33 encompass preventing or treating ANY individual (the recitation of the individual as being identified by the method of claim 18 is interpreted as non-limiting, see Claim Interpretation section above) with ANY type of cancer, claims 34 and 36-37 encompass preventing or treating ANY individual for recurrence of ANY cancer, claim 19 encompasses identifying and treating ANY individual with breast cancer, claim 31 encompasses preventing or treating ANY individual with breast cancer, and claim 35 encompasses preventing or treating ANY individual for recurrence of breast cancer.
Teachings in the Specification and Examples
In Example 1, the instant specification teaches a biomarker signature of the response of breast cancer cells to the mitochondrial-targeted antioxidant MitoQ using human breast cancer cell lines and human breast cancer tumors grown in mice, a limited subset of the biomarkers (SLC7A11, SERPINE1, and TXNRD1) in spontaneous breast cancer in mice, and the treatment and reduction of metastasis and recurrence in human breast cancer implanted in mice. In Example 3, the instant specification further teaches that the biomarker signature identified in Example 1 is applicable to the treatment of breast cancer cells with the mitochondrial-targeted antioxidant SKQ1 using human breast cancer cell lines. However, this does not teach that the biomarker signature is indicative of a response of any other type of cancer cell to treatment with mitochondria-targeted antioxidants. This also does not teach the prevention of any cancer by administration of a mitochondria-targeted antioxidant (in [0308] the total primary tumor weight was not altered, so there is no evidence that cancer was prevented), the treatment of any cancer other than breast cancer by administration of a mitochondria-targeted antioxidant, or the prevention or treatment of recurrence of any cancer other than breast cancer. The instant specification teaches that the individual may be any of various mammals and the cancer of the method may be various different types of cancers (see [0139]-[0154]), but it does not limit the individual or the cancer, nor does it further connect the teachings of the examples with other types of individuals or cancers such that they would be enabled.
State of the Art and Unpredictability of the Art
The claims broadly encompass methods relating to identifying and treating an individual that has or can get any cancer and preventing and/or treating any cancer or recurrence of any cancer. However, the specification only provides support for identifying as susceptible and treating human individuals with breast cancer and treating/preventing recurrence of a primary human breast cancer tumor grown in mice. The prior art of Xu et al. (“A Comparative Analysis of Gene-Expression Data of Multiple Cancer Types”, PLoS One 5(10):e13696 (2010)) teaches that they sought to identify genes that could be used as indicators for cancer in general or for a group of cancers. They examined differentially expressed genes with at least 2-fold changes between cancer and corresponding control tissues across seven different cancer types (breast, colon, kidney, lung, pancreas, prostate, stomach). Only 85 genes were differentially expressed across 3 cancer types, 19 genes were differentially expressed across 4 cancer types, and 5 genes were differentially expressed among 5 cancer types (page 5). Thus, with regard to claims 18-29 it is highly unpredictable as to whether the findings in the specification regarding the correlation of the amount of three or more biomarkers of SLC7A11, SERPINE1, PSAT1, PHGDH-1, TXNRD1, VIM, SNAI1, ZEB1, NANOG, SOX2, PCK2, G6PD, ASNS, NUPR1, and SLC6A9 with treatment of breast cancer using a mitochondria-targeted antioxidant could be extrapolated to any type of cancer.
Regarding claims 30-37, Kalyanaraman et al. (US Patent Application Publication Cite No 1 in IDS filed 21 November 2023)(US 2008/0032940) teaches the use of a mitochondria-targeted antioxidant, MitoQ, to treat neuroblastoma, prostate cancer, and breast cancer based on its differential effect on healthy cells compared to cell lines from human neuroblastoma, prostate cancer, and breast cancer patients (Example 2 on page 4). Therefore, the art further enables treatment of not just breast cancer but also neuroblastoma and prostate cancers.
The claims broadly encompass a methods relating to cancer in ANY individual, encompassing all animals that can get cancers such as humans, mice, dogs, fish, and insects. However, the specification only enables identifying and treating breast cancer using the claimed biomarkers in human cells, a correlation between the expression of only SLC7A11, SERPINE1, and TXNRD1 with breast cancer in mice, and preventing and treating cancer recurrence in mice. The prior art teaches that there is a large amount of unpredictability with regard to comparing results from gene expression analysis in humans to even closely related animals. For example, Coleman (“Of mouse and man – what is the value of the mouse in predicting gene expression in humans?” Drug Discov Today, 8(6) pages 233-235 (2003)) found that while gene expression patterns between mice and humans shared some degree of similarity, the basic patterns of gene expression differed and that there was no general rule for predicting gene expression (page 2 paragraph 3 through page 3). Coleman concluded that “The validity of mouse or other animal species as a human surrogate should not be assumed” (emphasis added). These teachings of Coleman support the finding that there is no predictable means for determining whether the correlation of the claimed biomarkers with breast cancer in humans and SLC7A11, SERPINE1, and TXNRD1 with breast cancer in mice can be extended to all individuals capable of having any cancer. Furthermore, Mak et al. (“Lost in translation: animal models and clinical trials in cancer treatment” Am J Transl Res 6(2), pages 114-118 (2014)) found that “the average rate of successful translation from animal models to clinical cancer trials is less than 8%. Animal models are limited in their ability to mimic the extremely complex process of human carcinogenesis, physiology and progression. Therefore the safety and efficacy identified in animal studies is generally not translated to human trials” (Abstract). This illustrates the high unpredictability of applying the findings of an effective treatment for cancer in one type of animal to treatment or prevention of cancer in individuals of another type of animal.
Therefore, the state of the art and teachings of the specification enable claims 18-29 with regard to human individuals with breast cancer, but not with other individuals or other cancers, claims 30-33 with regard to treating human individuals with neuroblastoma, prostate, or breast cancers or mice with breast cancer, but not treatment of other combinations of individual and cancer or prevention of any cancer in any individual, and claims 34-37 with regard to preventing and treating cancer recurrence in mice with human breast cancer, but not prevention or treatment of cancer recurrence of other combinations of individual and cancer.
Quantity of Experimentation
The quantity of experimentation necessary to enable the full scope of the claims is undue. In order to practice the breadth of the claimed invention of claims 18-29 (with claim 19 limited to breast cancer), one of ordinary skill in the art would need to verify that every possible combination of at least three biomarkers selected from SLC7A11, SERPINE1, PSAT1, PHGDH-1, TXNRD1, VIM, SNAI1, ZEB1, NANOG, SOX2, PCK2, G6PD, ASNS, NUPR1 and SLC6A9 is associated with treatment of a sufficiently large number of cancers with mitochondria-targeted antioxidant(s) to be representative of every type of cancer and to do so in a sufficiently large number of individuals (including individuals as diverse as dogs, lizards, flies, fish, etc.) to be representative of every type of individual encompassed by the claims. In order to practice the breadth of the claimed invention of claims 30-33 (with claim 31 limited to breast cancer), one of ordinary skill in the art would need to show that a therapeutically efficient amount of at least one mitochondria-targeted antioxidant can be used to both prevent and treat a sufficiently large number of cancers to be representative of every type of cancer and to do so in a sufficiently large number of individuals (including individuals as diverse as dogs, lizards, flies, fish, etc.) to be representative of every type of individual encompassed by the claims. In order to practice the breadth of the claimed invention of claims 34-37 (with claim 35 limited to breast cancer), one of ordinary skill in the art would need to show that a therapeutically efficient amount of at least one mitochondria-targeted antioxidant can be used to both prevent and treat recurrence of a sufficiently large number of cancers to be representative of every type of cancer and to do so in a sufficiently large number of individuals (including individuals as diverse as dogs, lizards, flies, fish, etc.) to be representative of every type of individual encompassed by the claims. The specification has not done any of the above. The results of such experimentation are highly unpredictable. The amount of experimentation that would be required to practice the full scope of the claimed invention and the amount of time and cost this experimentation would take supports the position that such experimentation is undue (see MPEP §2164.06).
Conclusions
Herein, although the level of ordinary skill in the art is high, given the lack of disclosure in the specification and in the prior art and the unpredictability of the art, it would require undue experimentation for one of ordinary skill in the art to make and use the full scope of the invention as broadly claimed in claims 18-37.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 18-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. While the claims are directed to a process, and therefore meet step 1 of the subject matter eligibility test (see MPEP §2106.03), the claim(s) recite(s) the abstract ideas of comparing the expression levels and identifying an individual with cancer as being susceptible to respond to a treatment when a significant variation of the expression levels is observed, which are mental processes because they can be done in the human mind looking at data.
Step 2A of the subject matter eligibility test require a two-pronged analysis. Prong One asks: does the claim recite an abstract idea, law of nature or natural phenomenon? As discussed in MPEP §2106.04(II)(A)(1), the meaning of “recites” is “set forth” or “describes”. That is, a claim recites a judicial exception when the judicial exception is “set forth” or “described” in the claim. In the instant case, the claims describe abstract ideas of comparing expression levels and of identifying an individual with cancer as being susceptible to respond to a treatment when a significant variation of expression levels is observed.
Prong Two of the analysis under step 2A asks: does the claim recite additional elements that integrate the judicial exception into a practical application of the judicial exception? As discussed in MPEP §2106.04(II)(A)(2):
Because a judicial exception is not eligible subject matter, Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06 (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)), if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. See, e.g., RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"); Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016) (eligibility "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself."). For a claim reciting a judicial exception to be eligible, the additional elements (if any) in the claim must "transform the nature of the claim" into a patent-eligible application of the judicial exception, Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1981, either at Prong Two or in Step 2B.
The considerations to be used are set forth in MPEP §2106.04(d)(2) and MPEP §2106.05(a) through (c) and (e) through (h). Turning to those sections of the MPEP:
MPEP §2106.05(a) has to do with improvements to the functioning of a computer or to any other technology or technical field. The claims at issue do not improve the functioning of a computer or improve the technical field of cancer treatment.
MPEP §2106.05(b) has to do with whether the claims involve the use of a particular machine. In this case, the claims do not involve the use of a particular machine as all materials used in steps of the method are described generically.
MPEP §2106.05(c) has to do with whether the claims involve a particular transformation. Here, the claims do not involve a particular transformation because the claims are for a process.
MPEP §2106.05(e) has to do with “other meaningful limitations”. The additional limitations imposed upon the abstract ideas consist of assessing the expression levels of at least three biomarkers selected from the group consisting of SLC7A11, SERPINE1, PSAT2, PHGDH-1, TXNRD1, VIM, SNAI1, ZEB1, NANOG, SOX2, PCK2, G6PD, ASNS, NUPR1 and SLC6A9, in samples obtained from said individual before and after treatment with said mitochondria-targeted antioxidant and treating the individual being susceptible to respond to a treatment by a mitochondria-targeted antioxidant identified at step c), by administering a therapeutically efficient amount of said at least one mitochondria-targeted antioxidant. These are not meaningful limitations because they generally link the use of the judicial exceptions to the particular technological environment of cancer treatment.
MPEP §2106.04(d)(2) has to do with whether the additional elements apply or use the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. While the recited step of “administering a therapeutically efficient amount of said at least one mitochondria-targeted antioxidant” is a particular treatment, it is only done to those individuals identified in step c) when a significant variation of the expression levels is observed at step b). Since the claim does not limit what individuals the method is applied to, individuals for who there is no significant variation of the expression levels observed at step b) would not be identified and would not receive a particular treatment. As the method claimed can be accomplished without particular treatment in the case of individuals without the significant variation of the expression levels, the judicial exception is not applied to effect a particular treatment or prophylaxis for a disease or medical condition.
MPEP §2016.05(f) raises the question as to whether the additional elements recited in the claim represent “mere instructions to apply an exception”. As step a) gathers data that is used in the abstract ideas of comparing and identifying and the abstract ideas of comparing and identifying are applied by step d) of administering a treatment to identified individuals, the additional elements represent mere instructions to apply the exceptions.
MPEP §2106.05(g) has to do with whether the additional elements of the claim amount of insignificant extra-solution activity. MPEP §2106.05(g) notes that “[d]etermining the level of a biomarker in blood” is an example of “mere data gathering” which the courts have found to be insignificant extra-solution activity. Therefore, step a) of assessing the expression levels of biomarkers used in the abstract ideas of comparing and identifying is mere data gathering.
MPEP §2106.05(h) has to do with whether the additional elements amount to more than generally linking the use of a judicial exception to a particular technological environment or field of use. The recitation of the judicial exceptions being applied to cancer treatment represent “field of use” limitations. However, as MPEP §2106.05(h) indicates, such limiting to a particular “field of use” does not confer patentability to otherwise ineligible subject matter.
In addition, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception (as set forth in step 2B of the subject matter eligibility test), Courts have recognized that laboratory techniques including determining the level of a biomarker as well-understood, routine, conventional activity, so the additional element of assessing the expression levels of at least three biomarkers selected from the recited list is well-understood, routine, conventional activity. The other additional element of treating the individual identified is conditional on the significant variation of the expression levels being observed and is not required for the claimed method to be practiced. Therefore, the additional elements are not enough for the claim to amount to significantly more than the judicial exception.
Having considered the factors discussed in MPEP §2106.04 and §2106.05, it is clear that the additional elements recited in the claims, whether considered individually or as a combination, do not integrate the judicial exceptions into a practical application of those exceptions in such a way as to provide meaningful limits on the use of the judicial exception and do not amount to significantly more than the judicial exception. Therefore, claims 18-29 are rejected here under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 30-37 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Kalyanaraman et al. (US Patent Application Publication Cite No 1 in IDS filed 21 November 2023)(US 2008/0032940, published 7 February 2008, effectively filed 7 August 2006), herein Kalyanaraman.
Regarding claims 30 and 34, Kalyanaraman teaches a method for treating and/or preventing breast cancer, prostate cancer, and neuroblastoma, comprising the administration of a therapeutically efficient amount of at least one mitochondria-targeted antioxidant (“A method for treating a subject having a cancer comprising the step of: administering an effective amount of a mitochondria-targeted antioxidant to a subject having or susceptible to a cancer so that the cancer is reduced” Claim 1; Example 2 on page 4 enabling treatment of breast cancer, prostate cancer, and neuroblastoma). As discussed in the Claim Interpretation section above, the intended uses recited in the preamble of claims 30 and 34 are interpreted as non-limiting and therefore Kalyanaraman does not have to teach the intended uses in order to anticipate the claims. Furthermore, even if the intended uses were interpreted as limiting the scope of the respective claims, MPEP §2111.02 II. states: “To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim.” As the method of Kalyanaraman is taught for the purpose of treatment and prevention of cancer, one of ordinary skill in the art would understand that method of Kalyanaraman is capable of being performed to prevent or treat cancer in any individual having or being susceptible to cancer such as those defined in the intended uses recited in claims 30 and 34. Therefore, Kalyanaraman teaches a method comprising all limitations of claims 30 and 34 and would satisfy the non-limiting intended uses even if the intended uses were interpreted as limiting.
Regarding claims 31 and 35, Kalyanaraman teaches the methods of claims 30 and 34 (see 35 U.S.C. 102 rejection of claims 30 and 34 above), wherein the cancer is breast cancer (“A method as recited in claim 1, wherein the cancer is selected from the group consisting of […] breast cancer” Claim 7).
Regarding claims 32 and 36, Kalyanaraman teaches the methods of claims 30 and 34 (see 35 U.S.C. 102 rejection of claims 30 and 34 above), wherein the at least one mitochdonria-targeted antioxidant is MitoQ or SKQ1 or a functional derivative thereof (“A method as recited in claim 1, wherein the mitochondria-targeted antioxidant is MitoQ” Claim 3).
Regarding claims 33 and 37, Kalyanaraman teaches the methods of claims 30 and 34 (see 35 U.S.C. 102 rejection of claims 30 and 34 above), wherein the antioxidant is further combined with another cancer treatment (“A method as recited in claim 1, further including co-administering an effective amount of an anthracycline” Claim 2).
Therefore, claims 30-37 are anticipated by Kalyanaraman.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 18-20 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Lissoni et al. (“Modulation of cancer endocrine therapy by melatonin: a phase II study of tamoxifen plus melatonin in metastatic breast cancer patients progressing under tamoxifen alone” Br J Cancer 71(4), pages 854-856 (1995)), herein Lissoni, in view of Akbarzadeh et al. (“The potential therapeutic effect of melatonin on human ovarian cancer by inhibition of invasion and migration of cancer stem cells” Sci Rep 7(1): 17062 (2017)), herein Akbarzadeh.
Regarding claim 18, Lissoni teaches a method of treating cancer with melatonin and identifying the efficacy of the melatonin treatment comprising assessing the expression levels of the biomarkers IGF-1 and PRL in samples obtained from an individual before and after treatment with melatonin (MLT), which is a mitochondria-targeted antioxidant (“MLT […] was administered orally at a daily dose of 20 mg in the evening every day of [tamoxifen] therapy starting 7 days before [tamoxifen], as an induction phase. […] serum levels of IGF-1 and PRL were also measured before treatment at 1 month intervals” page 854 right column paragraph 2 to page 855 left column paragraph 3), and comparing the expression levels of the biomarkers in the samples obtained after treatment with expression levels of the biomarkers in the samples obtained before treatment (“Changes in mean serum levels of IGF-1 observed on study are illustrated in Figure 1. Mean concentrations of IGF-1 significantly decreased on treatment with respect to the values found before therapy […] Mean PRL levels also significantly decreased on treatment with respect to the pretreatment ones” page 855 right column paragraph 2; Figure 1). Lissoni also teaches that “measurements of other prognostic variables, such as progesterone and MLT receptors, will have to be evaluated to better define possible predictive factors for MLT efficacy” (page 856 left column paragraph 1), which motivates one of ordinary skill in the art to combine the method of Lissoni with other biomarkers associated with treatment of cancer with therapies similar to melatonin. As discussed in the Claim Interpretation section above, steps c) and d) of claim 18 are contingent and therefore not required for the method to be practiced.
However, Lissoni does not teach assessing the expression levels of at least three biomarkers or that those three biomarkers are selected from the group consisting of SLC7A11, SERPINE1, PSAT1, PHGDH-1, TXNRD1, VIM, SNAI1, ZEB1, NANOG, SOX2, PCK2, G6PD, ASNS, NUPR1 and SLC6A9. Examiner notes that the elected species of three or more biomarkers (SLC7A11, SERPINE1, and PSAT1) is not anticipated by or obvious over the prior art (see Claims Free of the Prior Art section below). As a result, species of three or more biomarkers including SLC7A11, SERPINE1, PSAT1, PHGDH-1, TXNRD1, VIM, SNAI1, ZEB1, NANOG, and SOX2 have been searched and examined. This deficiency is made up for in the teachings of Akbarzadeh.
Regarding claim 18, Akbarzadeh teaches that treatment of cancer stem cells with melatonin leads to significant changes in expression levels of VIM (vimentin), SNAI1 (Snail), and ZEB1 (“EMT and invasion associated genes, vimentin, ZEB1, ZEB2, snail, were highly expressed in CSCs compared to SKOV3 cells (Fig. 4e–i). Incubation of the cells with melatonin (3.4 mM) for 48 h decreased the expression of these genes in both CSCs and SKOV3 (Fig. 4e–h)” page 3 paragraph 3; see also Figure 4e, 4g, and 4h, note the significant variation in ZEB1, Snail, and Vimentin expression in CSCs treated with melatonin compared to control CSCs). This would teach one of ordinary skill in the art that the expression of the three biomarkers ZEB1, SNAI1, and VIM together provide information on the response of cancer to melatonin. Akbarzadeh also teaches that treatment of cancer stem cells with melatonin leads to significant changes in expression levels of NANOG and SOX2 (“Nanog mRNA expression level revealed almost six fold increase in CSCs compared to SKOV3 cells which was completely diminished after 48 h incubation with melatonin (3.4 mM) (Fig. 2d). SOX2 mRNA level in CSCs was also significantly higher in CSCs than that level in SKOV3 cells (p < 0.05) which was also decreased after incubation with melatonin (p < 0.05) (Fig. 2e)” page 2 paragraph 4; see also Figure 2d and 2e). This would teach one of ordinary skill in the art that NANOG and SOX2 are also biomarkers providing information on the response of cancer to melatonin.
Regarding claim 19, the combination of Lissoni and Akbarzadeh teach the method according to claim 18 (see 35 U.S.C. 103 rejection of claim 18 above), and Lissoni further teaches the method wherein the cancer is breast cancer (“The study included 14 consecutive women with metastatic breast cancer” page 854 right column paragraph 2).
Regarding claim 20, the combination of Lissoni and Akbarzadeh teach the method according to claim 18 (see 35 U.S.C. 103 rejection of claim 18 above), and Akbarzadeh further teaches that melatonin treatment leads to variation of at least 1.2 fold in the expression levels of VIM, SNAI1, ZEB1, NANOG, and SOX2 compared to untreated controls (Figure 2d and 2e, Figure 4e, 4g, and 4h).
Regarding claim 26, the combination of Lissoni and Akbarzadeh teach the method according to claim 18 (see 35 U.S.C. 103 rejection of claim 18 above), and Akbarzadeh further teaches the assessment of the expression levels of VIM, SNAI1, ZEB1, NANOG, and SOX2 at the nucleic acid level (“real-time RT-PCR” Figure 2 legend regarding Figure 2d and 2e as well as Figure 4 legend regarding Figure 4e-i).
Regarding claim 27, the combination of Lissoni and Akbarzadeh teach the method according to claim 18 (see 35 U.S.C. 103 rejection of claim 18 above), and Lissoni further teaches the method wherein the cancer is a metastatic cancer (“The study included 14 consecutive women with metastatic breast cancer” page 854 right column paragraph 2).
Regarding claim 28, the combination of Lissoni and Akbarzadeh teach the method according to claim 18 (see 35 U.S.C. 103 rejection of claim 18 above), and Lissoni and Akbarzadeh both further teach the method wherein the mitochondria-targeted antioxidant is melatonin (“MLT […] was administered” Lissoni page 854 right column paragraph 2; Akbarzadeh Figures 2d, 2e, 4e, 4g, and 4h).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to perform the simple substitution of the biomarkers ZE
B1, SNAI1, and VIM (and NANOG and SOX2) that are informative about the response of cancer to melatonin as taught by Akbarzadeh for the biomarkers IGF-1 and PRL that are used in the method of Lissoni to provide information about the response of cancer to melatonin (MPEP §2143 I. B.). One of ordinary skill in the art would also be motivated to perform this substitution because Lissoni provides explicit motivation to apply their method to other prognostic variables for obtaining information on the efficacy of treating cancer with melatonin (Lissoni page 856 left column first paragraph). One of ordinary skill in the art could have performed this substitution and would have found the results of this substitution predictable because measuring biomarkers is a standard procedure in the field and Akbarzadeh teaches primers for measuring the biomarkers. Therefore, the invention as a whole of claims 18-20 and 26-28 would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Lissoni et al. (“Modulation of cancer endocrine therapy by melatonin: a phase II study of tamoxifen plus melatonin in metastatic breast cancer patients progressing under tamoxifen alone” Br J Cancer 71(4), pages 854-856 (1995)), herein Lissoni, in view of Akbarzadeh et al. (“The potential therapeutic effect of melatonin on human ovarian cancer by inhibition of invasion and migration of cancer stem cells” Sci Rep 7(1): 17062 (2017)), herein Akbarzadeh as applied to claims 18-20 and 26-28 above, and further in view of Reiter et al. (“Melatonin as a mitochondria-targeted antioxidant: one of evolution’s best ideas” Cell Mol Life Sci 74(21), pages 3863-3881 (2017)), herein Reiter.
Regarding claim 29, the combination of Lissoni and Akbarzadeh teach the method according to claim 18 (see 35 U.S.C. 103 rejection of claim 18 above). However, Lissoni and Akbarzadeh teach the method wherein the at least one mitochondria-targeted antioxidant is melatonin, not MitoQ or SKQ1 or a functional derivative thereof. This deficiency is made up for in the teachings of Reiter.
Regarding claim 29, Reiter teaches that both melatonin and MitoQ are mitochondrial-targeted antioxidants (“The best known mitochondria-targeted antioxidants are MitoQ” page 3874 left column paragraph 1; “melatonin is a mitochondria-targeted antioxidant” page 3874 right column paragraph 3).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to perform the simple substitution of MitoQ as the mitochondria-targeted antioxidant, as taught by Reiter, for melatonin as the mitochondria-targeted antioxidant in the method of the combination of Lissoni and Akbarzadeh (MPEP §2143 I. B.). One of ordinary skill in the art could have performed this substitution and would have found the results of this substitution predictable because both MitoQ and melatonin are taught to perform the same function of being a mitochondria-targeted antioxidant. Therefore, the invention as a whole of claim 29 would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention.
Claims Free of the Prior Art
Claims 21-25 are free of the prior art, but stand rejected under 35 U.S.C. 101, 112(a), and 112(b) as discussed above.
The nearest prior art to claim 23 is the combination of Lissoni and Akbarzadeh (as discussed regarding claim 18 in the 35 U.S.C. 103 rejection of claim 18 above). However, neither Lissoni nor Akbarzadeh teach any of SLC7A11, SERPINE1, PSAT1, PHGDH-1, or TXNRD1 as being biomarkers informative on the response of cancer to treatment with a mitochondria-targeted antioxidant.
For SLC7A11, though prior art such as Koppula et al. (Non-Patent Literature Document Cite No 17 in the IDS filed 29 January 2024)(“Amino acid transporter SLC7A11/xCT at the crossroads of regulating redox homeostasis and nutrient dependency of cancer” Cancer Commun (Lond) 38(1): 12 (2018)) teaches that SLC7A11 is associated with human cancers (Abstract) and is involved in the antioxidant response (“Thus, SLC7A11 is one of the NRF2 transcriptional targets that mediate the antioxidant response” page 8 left column paragraph 1), no prior art teaches an association between SLC7A11 and the response of cancer to treatment with mitochondria-targeted antioxidants that would make it obvious to use as a biomarker in the method of the combination of Lissoni and Akbarzadeh.
For SERPINE1, though prior art such as Li et al. (Non-Patent Literature Document Cite No 16 in the IDS filed 29 January 2024)(“Plasminogen activator inhibitor-1 in cancer research” Biomed Pharmacother 105, pages 83-94 (2018)) teaches that SERPINE1 is a prognostic biomarker for cancers including breast cancer (section titled “2. Prognostic value of PAI-1 in different cancer types” page 83 right column paragraph 3 onwards), no prior art teaches an association between SERPINE1 and the response of cancer to treatment with mitochondria-targeted antioxidants that would make it obvious to use as a biomarker in the method of the combination of Lissoni and Akbarzadeh.
For PSAT1, though prior art such as Wang et al. (Non-Patent Literature Document Cite No 15 in the IDS filed 29 January 2024)(“Overexpression of PSAT1 regulated by G9A sustains cell proliferation in colorectal cancer” Signal Transduct Target Ther 5(1): 47 (2020)) teaches that PSAT1 is overexpressed in multiple cancer types including breast cancer (“Overexpression of PSAT1 was found in non-small cell lung cancer, breast cancer, and esophageal squamous cell carcinoma and was shown to enhance tumorigenesis and metastasis” page 1 left column paragraph 1), no prior art teaches an association between PSAT1 and the response of cancer to treatment with mitochondria-targeted antioxidants that would make it obvious to use as a biomarker in the method of the combination of Lissoni and Akbarzadeh.
For PHGDH-1, though prior art such as Zhao et al. (Non-Patent Literature Document Cite No 14 in the IDS filed 29 January 2024)(“The Role of D-3-Phosphoglycerate Dehydrogenase in Cancer” Int J Biol Sci 16(9), pages 1495-1506 (2020)) teaches that PHGDH-1 is overexpressed in multiple cancer types including breast cancer (“To date, it has been reported that the level of PHGDH protein is increased in 16% of all cancers, 40% of melanoma samples, 70% of estrogen receptor (ER)-negative and triple-negative breast cancer samples, and even associated with subtypes of breast cancers” page 1497 right column paragraph 2), no prior art teaches an association between PHGDH-1 and the response of cancer to treatment with mitochondria-targeted antioxidants that would make it obvious to use as a biomarker in the method of the combination of Lissoni and Akbarzadeh.
For TXNRD1, though prior art such as Harris et al. (“Glutathione and thioredoxin antioxidant pathways synergize to drive cancer initiation and progression” Cancer Cell 27(2), pages 211-222 (2015)) teaches that TXNRD1 interacts with reactive oxygen species levels and is upregulated in breast cancer (“The TXN pathway can efficiency reduce ROS levels and be regenerated by TXNRD” page 216 right column paragraph 2; “examination of “The Cancer Genome Atlas” (TCGA) breast cancer data set revealed XCT, TXN1, and TXNRD1 to be upregulated in breast cancer patient tissue compared to normal tissue” page 217 left column paragraph 1), no prior art teaches an association between TXNRD1 and the response of cancer to treatment with mitochondria-targeted antioxidants that would make it obvious to use as a biomarker in the method of the combination of Lissoni and Akbarzadeh.
Since it would not be obvious to use any of SLC7A11, SERPINE1, PSAT1, PHGDH-1, or TXNRD1 as a biomarker for informing on the response of cancer to mitochondria-targeted antioxidants, claim 23 is free of the prior art. Additionally, since claim 21 requires that the biomarkers selected include any of SLC7A11, SERPINE1, or PSAT1, claim 22 requires that the biomarkers selected include SLC7A11, SERPINE1, and PSAT1, claim 24 requires that the biomarkers selected include SLC7A11, SERPINE1, PSAT1, PHGDH-1, and TXNRD1, and claim 25 requires that the biomarkers selected are SLC7A11, SERPINE1, PSAT1, PHGDH-1, TXNRD1, VIM, SNAI1, ZEB1, NANOG, SOX2, PCK2, G6PD, ASNS, NUPR1, and SLC6A9, claims 21-22 and 24-25 are also free of the prior art due to all being narrower than claim 23 which is free of the prior art. Therefore, claims 21-25 are free of the prior art.
Conclusion
Claims 18-37 are rejected. Claims 1-17 are canceled.
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/JEFFREY BELLAH/Examiner, Art Unit 1683
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
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